18F-AV-1451 PET Imaging in TBI

TBI Subjects

Inclusion Criteria:

TBI Subjects

- Subjects that have consented and are currently enrolled in either Transforming
Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), Evaluation,
Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury
Protocol Number: CNS: 10-N-N122, or Evaluation and Diagnosis of Potential Research
Subjects with Traumatic Brain Injury (TBI): Protocol Number: 11-N-0084

- History of having sustained a TBI < 6 weeks prior to enrollment

- Can tolerate PET and MRI scan procedures

Control Subjects

- MMSE ≥ 28

- No significant history of cognitive impairment

- No prior history of TBI

- Can tolerate PET and MRI scan procedures

Exclusion Criteria:

- Have behavior dysfunction that is likely to interfere with imaging

- Are claustrophobic or otherwise unable to tolerate the imaging procedure

- Have current clinically significant cardiovascular disease, or clinically significant
abnormalities on screening ECG

- A history of additional risk factors for Torsades de Pointes (TdP) or are taking
drugs that are known to cause QT-prolongation

- Have a current clinically significant infectious disease, endocrine or metabolic
disease, pulmonary, renal or hepatic impairment, or cancer

- Are females of childbearing potential who are not surgically sterile, not refraining
from sexual activity or not using reliable methods of contraception

- Have had a non-study related radiopharmaceutical imaging or treatment procedure
within 7 days prior to the 18F-AV-1451 imaging session

- Have current alcohol dependence or alcohol dependence within the past 1 year

- Are currently participating in another interventional clinical trial

- Have evidence of a penetrating brain injury

- Have participated in contact sports in college or after high school age